← Back to catalogue
Screw Rack 3.5mm L65 - L90
EUDAMEDFDA UDIClass I (EU MDR)
Ref B-420021Model Bonebridge Instrument-Ir
Identity
- Trade Name
- Screw Rack 3.5mm L65 - L90 EUDAMEDScrew Rack 3.5mm L65 – L90 FDA UDI
- Generic Name
- Surgical instrument/implant rack FDA UDI
- Device Name
- Bonebridge Instrument-Ir EUDAMED
- Model / Reference
- Bonebridge Instrument-Ir EUDAMEDB-420021 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640187461701 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018746InstrumentsIrTM EUDAMED
- Direct Marketing DI
- 07640187461701 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical instrument/implant rack FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Screw Rack 3.5mm L65 - L90 by Bonebridge AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764018746InstrumentsIrTM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bonebridge AG
- EUDAMED SRN
- CH-MF-000013933
- Authorised Representative
- Axxos GmbH DE-AR-000005590
Sources (3)
- EUDAMED 749a643a-19cd-46e1-b734-6b2b844c283d 61 fields · synced Jul 10, 2026
- FDA UDI a6d5a6e3-4580-4bce-8f0e-1a5d3496eca2 32 fields · synced May 30, 2026
- EUDAMED 72676ab6-4fe0-4a87-9e12-97fda5d97f70 61 fields · synced Jul 10, 2026